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To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.
Surgical Theater is a company that has developed a platform which can be used to describe and explain spinal surgery to patient before they undergo the procedure. The platform specifically implements data from the patient's own MRI and CT scans, creating a 3d reconstruction that can be seen through a virtual reality lens. This technology was developed to help clarify any concerns patient's may have before surgery, and help them better appreciate what will occur in the OR.
Surgical theater has FDA clearance for patient interaction and engagement. Our study is to take surgical theater into our clinics and, after a patient is defined as a surgical candidate, use surgical theater to provide spatial learning and comprehension through modeling so they better understand their surgical plan. Only the SRP system will be used for this study (Surgical Planner).
The intervention is showing surgical theater to patients identified for surgery in clinic routinely. Surgical theater will be offered to all patients offered surgery. No other changes in practice will be done.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of usefulness | Experimental | To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Theater | Device | The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline EQ-5D Health-Related Quality of Life at 6 Months After Surgery | Reports on 5 dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression. Each score from 1-3 with 1.0 being perfect health. | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) |
| Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery | 0-10 Scale to assess how pain affects the ability to function across 15 categories. o 0 (optimal function) to 150 (total disability) | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) |
| Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery | Understanding - before and after consult, Anxiety level - before and after consult, Satisfaction with consult, HCAHPS - Overall rating of hospital, Satisfied = 9 or 10 rating | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Smith, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States | ||
| University Hospitals at Southwest General Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31331747 | Background | Altieri R, Melcarne A, Junemann C, Zeppa P, Zenga F, Garbossa D, Certo F, Barbagallo G. Inferior Fronto-Occipital fascicle anatomy in brain tumor surgeries: From anatomy lab to surgical theater. J Clin Neurosci. 2019 Oct;68:290-294. doi: 10.1016/j.jocn.2019.07.039. Epub 2019 Jul 19. | |
| 24051875 | Background | Bambakidis NC, Selman WR, Sloan AE. Surgical rehearsal platform: potential uses in microsurgery. Neurosurgery. 2013 Oct;73 Suppl 1:122-6. doi: 10.1227/NEU.0000000000000099. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Evaluation of Usefulness | To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults. Surgical Theater: The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Evaluation of Usefulness | To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults. Surgical Theater: The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline EQ-5D Health-Related Quality of Life at 6 Months After Surgery | Reports on 5 dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression. Each score from 1-3 with 1.0 being perfect health. | Data not collected | Posted | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evaluation of Usefulness | To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults. Surgical Theater: The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gabriel Smith | University Hospitals Cleveland Medical Center | (440)827-5088 | Gabriel.Smith@UHhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2019 | Jan 4, 2023 | Prot_SAP_001.pdf |
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| Middleburg Heights |
| Ohio |
| 44130 |
| United States |
| 29256988 | Background | Ehlers JP, Uchida A, Srivastava SK. THE INTEGRATIVE SURGICAL THEATER: Combining Intraoperative Optical Coherence Tomography and 3D Digital Visualization for Vitreoretinal Surgery in the DISCOVER Study. Retina. 2018 Sep;38 Suppl 1(Suppl 1):S88-S96. doi: 10.1097/IAE.0000000000001999. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery | 0-10 Scale to assess how pain affects the ability to function across 15 categories. o 0 (optimal function) to 150 (total disability) | Data not collected | Posted | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) |
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| Primary | Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery | Understanding - before and after consult, Anxiety level - before and after consult, Satisfaction with consult, HCAHPS - Overall rating of hospital, Satisfied = 9 or 10 rating | Data not collected | Posted | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) |
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| 7 |
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